Support device and method

ABSTRACT

Devices and methods for orthopedic support are disclosed. The device can have a first rigid section hingedly attached to a second rigid section. A tunnel through the bone near the implantation target site can be created. The device can be inserted into and pass through and out of the tunnel to the target site.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional of U.S. patent application Ser.No. 14/730,147 filed Jun. 3, 2015, which is a continuation of U.S.patent application Ser. No. 13/573,542 filed Sep. 21, 2012, nowabandoned, which claims the benefit of U.S. Provisional Application No.61/537,386 filed Sep. 21, 2011, each of which are herein incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

A device, such as a flexible spinal fusion cage, which can articulate orbend in such a way that it will be able to be implanted through bone(i.e., in a trans-osseous path, through bone, such as the Ilium and/orsacrum joint approach into L5-S1 is disclosed.

2. Description of the Related Art

Typical lateral approach fusion implants are not able to implant fusioncages in the lower lumbar region for at least two reasons. First, boneyobstacles can impair access. FIGS. 1a and 1b illustrate the challenge ofgaining lateral access to L4-L5 and L5-S1. Note the position of theIlium relative to the direct lateral access pathway. The Ilium obstructsthe target site for typical approaches to the respective disc spaces.

Some doctors create large windows, shown in phantom lines in FIG. 2,through the Ilium to gain direct line of site access. This is a highlyinvasive approach and requires significant surgical skill. Because ofthe inflexibility of the typical implants, the windows must be largeenough to fit the entire implant cross section.

Second, the approach angle of a tissue retractor relative to thelocation of the fusion site is an issue. The tissue retractor used inlateral fusion surgery provides line-of-site access to the disk spacethat is the target site for the fusion cage insertion. The retractorholds tissue out of the way. They also create a working channel to passtools through, they protect neural tissue, and they anchor to thesuperior and inferior vertebral bodies relative to the disk spacerequiring fusion. Anything inferior to the iliac crest's lateral plane10 is very hard, if not impossible, to reach with a direct lateralapproach due to the physical obstruction created by the position andshape of the Ilium. Even if the retractors are tilted as shown by anL1-S1 delivery path 11 a or L4-L5 delivery path 11 b and respectivelycorresponding L5-S1 approach angle 12 a and an L4-L5 approach angle 12b, the ability to insert an implant that is the length of the end platesof the L4 and L5 vertebral bodies would be very difficult.

Furthermore, with the retractor positioned in the plane and direction asshown by the delivery path 11 a, the approach angle 12 a formed betweenthe delivery path 11 a and the adjacent vertebral bodies' end plateswould make inserting a monolithic fusion cage virtually impossiblewithout severely damaging the surrounding vertebrae and/or the ilium.FIG. 5 illustrates that a typical lateral fusion cage 14 has a devicewidth 16 about equal to the width of the vertebral end plates and has adevice height 18 about equal to the height of the disk. The stiff andrigid monolithic implant can be difficult if not impossible to turnaround the corner 20 at the lateral and/or anterior edge of the L5-S1intervertebral space.

Typical treatments for L5-S1 include anterior approaches includeinsertion through the front of the abdomen, transforaminal lumbarinterbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF).Anterior and TLIF approaches are the most used. Both approaches arehighly invasive and destructive to surrounding tissue.

Accordingly devices and methods for lumbar stabilization that are lessdestructive to surrounding tissues are desired. For example, a deviceand method of inserting a strong support device through a minimalchannel in the ilium and/or ala that circumvent nerves and blood vesselsis desired.

SUMMARY OF THE INVENTION

Support or fixation devices and methods for access, controlling (e.g.,steering) implants, and modifying implants are disclosed.

The device can be an implantable fixation device, such as a flexiblefusion cage. The device can articulate and/or bend so the device can bedelivered through a channel in one or more bones and into the L5-S1intervertebral space, as shown in FIG. 6. The implant can articulate andbe steered. For example, the implant can have hinges and/or be flexible.

A stand-alone fusion system and method is disclosed that can includedeploying the support device with the transosseous delivery approach andoptionally deploying screws and using targeting fixtures.

A biological implant support device for providing orthopedic support isdisclosed. The device can have a first rigid section, and a second rigidsection. The first rigid section can be at a first terminal longitudinalend of the device. The second rigid section can be rotatably attached tothe first rigid section at a longitudinal end of the first rigid sectionaway from the first terminal longitudinal end of the device. The secondrigid section can have threads.

The device can have an axle rotatably attaching the first rigid sectionto the second rigid section.

A system for providing orthopedic support is disclosed that can have thethe support device described herein and a first screw attached to andextending away from device. The system can have a plug abutting thedevice.

A method for inserting a support device to a target site in a spineadjacent to a first vertebra is also disclosed. The method can includecreating a tunnel or channel through the ala of the sacrum. The methodcan include inserting a first rigid section of the device through thechannel and into the target site. The method can include inserting asecond rigid section of the device into the tunnel. The method caninclude rotating the second rigid section of the implant with respect tothe first rigid section. The first rigid section can be hingedlyattached to the second rigid section. The method can include fixing thesecond rigid section of the implant in the tunnel.

Creating the channel can include drilling with a flexible drill. Thechannel can have a cylindrical cross-section. The non-vertebral bone caninclude the pelvis, the ilium, the sacrum, or combinations thereof.

SUMMARY OF THE DRAWINGS

FIGS. 1a and 1b are direct anterior and anterior perspective views of avariation of the lower lumbar spine.

FIG. 2 is a lateral view of the lower lumbar spine with L5 and S1 shownin phantom views behind the Ilium.

FIG. 3 is the view of the spine shown in FIG. 1 with L5-S1 and L4-L5implant device delivery paths and approach angles.

FIG. 4 is the view of the spine shown in FIG. 2 with the L5-S1 implantdevice delivery path and approach angle.

FIG. 5 is the view of the spine shown in FIG. 3 with L5-S1 implantdevice shown being inserted along a delivery path at an approach angle.

FIGS. 6 and 7 are anterior and lateral views, respectively, of avariation of a delivery path for an implant device through the sacrum.

FIGS. 8a and 8b illustrate variations of and a delivery method for theimplant support device.

FIGS. 9a through 9c illustrate a variation of the implant support deviceand variations of delivery methods.

FIG. 10 illustrates a variation of a plug and a method for deliveringthe plug into the delivery channel through bone.

FIGS. 11a and 11b are superior views of the sacrum and variations ofmethods for deploying multiple implant devices.

DETAILED DESCRIPTION

Implantable orthopedic support devices and methods for implanting thesame that can access, control (i.e., steer) and deliver the devices intothe L5-S1 disc space are disclosed. A tunnel or bone channel 22 can bedrilled through the sacroiliac joint. The device 14 can be deliveredthrough the bone channel 22 and into the L5-S1 joint space. The deliverymethod can be performed without disrupting nerves and major bloodvessels. The implant has additional hardware to lock and/or stabilizethe implant (e.g., to make an articulatible or flexible implantunarticulatible or rigid) and connect and attach the L5 vertebra to theS1 vertebra.

The support device 14 can be one or more flexible fusion devices, suchas cages. The support devices 14 can articulate and/or bend, for exampleto be able to make a sharp turn from exiting a transosseous bone channel22 and entering into the L5-S1 disc space. The support devices 14 canhave rigid sections 24 connected by articulatable axes 26 (e.g.,hinges), or rigid sections 24 and flexible lengths (e.g., lengthsintegrated with the rigid sections that are made from a more flexiblematerial), or be flexible and/or resilient along the entire length ofthe device, or combinations thereof.

FIGS. 6 and 7 illustrate that the transosseous access bone (i.e.,access) channel 22 can be drilled in a position to exit to the L5-S1intervertebral disc space through the ala of the sacrum. The bonechannel 22 can be drilled through the Ilium and/or sacrum. The bonechannel 22 can be drilled with a straight and/or flexible orarticulatable drill. The bone channel 22 can be hollow.

The bone channel 22 can be fitted with a collar or tube in contact withthe perimeter of the channel. The collar or tube can be attached to atrocar. The tube can be delivered into the channel separate from atrocar. The tube can be hollow. The tube can have one, two, three ormore lumens. The implant device can be inserted through a lumen in thetube. The tube lumen(s) can have a low friction internal surface. Forexample, the internal surface of the lumen(s) can be coated with PTFE(e.g., Teflon).

FIG. 7 illustrates a lateral view of the lower spine. The transosseousaccess bone channel 22 can be oblique and non-perpendicular to thespine. The delivery (i.e., access) path 11 to the L4-L5 or L5-S1 discspace can be oblique and non-perpendicular to the spine. Thetransosseous delivery path 11 can be through bone (e.g., through theIlium and sacrum). The delivery path 11 can bypass all or majorarteries, veins, muscles, nerves or combinations thereof.

Access tools, such as elongated retractors that can be fit through thesuperficial incision and/or through the bone channel 22, can move softtissue out of the way to create access to the channel from the outsideof the patient's body. The distal end of the implant device 14 can beatraumatic. For example, the distal terminal end of the device 14 canhave a rounded tip to spread or dissect tissue away from the deliverypath 11 during translation of the device during delivery.

One or more deployment tools can deliver and deploy the support device14. The deployment tools can attach to the support device 14 to allowthe support device 14 to passively articulate or flex in response toresistive forces from surrounding tissue and/or to actively articulateor flex the support device 14 due to control inputs (e.g., pushing,twisting, button pressing, level manipulation, or combinations thereof)from the user. The interface or connection between the deployment tooland the support device 14 can manipulate the support device 14 bybending, flexing, steering, or combinations thereof. The deployment toolor tools can clear or debride the disk space (i.e., performing a partialor complete discectomy). The deployment tools can articulate and/or flexand follow the delivery paths shown for the support device 14 herein,for example to reach the L4-L5 and/or L5-S1 disc space. The deploymenttools can be pre-angled to reach and remove intervertebral disk tissue,for example the deployment tool can be rigid and bent or can flex andarticulate.

The support device 14 can fuse adjacent vertebrae to each other. Thesupport device 14 can be used with securing (e.g., nails and screws, forexample positioned through the support device 14 and one or both of theadjacent vertebrae) and/or targeting devices (e.g., radiopaque markers).

FIGS. 8a through 9c illustrate that additional securing devices andmethods can be used to fix, stabilize, help heal, minimize or preventmigration of the support device, reduce bone (e.g., L4, L5, S1, andcombinations thereof) movement relative to the support device andrelative to the other bones, and combinations thereof. The supplementstabilization elements 28 can secure the position of the flexibleimplant 14 to the surrounding bone. The support device 14 can completelyfuse to the ends plates of the surrounding bone (e.g., L4, L5, S1, andcombinations thereof). Other devices for fusing adjacent vertebrae, forexample facet fusion elements, pedicle screws and rods, anterior plates,and combinations thereof, can be used in combination with the supportdevice 14.

FIG. 8a illustrates that the support device 14 can be long enough and/orinserted at a length into the disc space so that a portion of thesupport device 14 can extend into the bone channel 22 after the device14 is inserted into and oriented in the intervertebral space. Theportion of the support device 14 inside of the bone channel 22 can bestraight or at an angle to the portion of the support device 14 directlyadjacent and on the outside of the bone channel 22. For example, thesupport device can be flexible through the distal ⅔ of the length of thesupport device and the proximal ⅓ of the length of the support devicecan be rigid or not flexible, but articulatable with the distal ⅔ of thelength of the support device. The proximal ⅓ of the length of thesupport device 14 can remain in the sacrum access tunnel or bone channelafter the support device 14 is positioned at the target site in the discspace. The stiff proximal section of the support device 14 can behingedly and/or flexibly connected to the distal length of the supportdevice 14. The support device 14 can be fixed to the bone channel, forexample at the proximal length of the support device 14. The proximalend of the support device can be glued, impacted, screwed, or acombination thereof, to the bone channel and/or to a collar in the bonechannel.

The proximal and/or distal ends of the support device 14 can have aporous bone ingrowth matrix on the outer surfaces of the support device14, for example promoting bone growth into the support device 14 fixingthe support device to surrounding bone (e.g., in the bone channel 22and/or L4, L5, and/or S1). The proximal, distal or entire length of thesupport device 14 can be hollow, cannulated, threaded, have teeth, beexpandable, barbed, be multiple pieces, or combinations thereof (e.g.,to promote bone growth into the support device). Any or all of thehollow lengths of the support device 14 can be filling with the boneingrowth matrix before, during or after the device 14 is positioned atthe target site.

After the device 14 is positioned at the target site, a screw plug 28can be inserted, as shown by arrow, through the bone channel 22. Thescrew plug 28 can have helical threads that can have an outer diameterlarger than the diameter of the bone channel 22. The screw plug can behelically rotated through the bone channel 22. The screw plug 28 canfill the bone channel 22. The screw plug 28 can be at the distal orproximal end of the bone channel 22. The screw plug 28 can abut thedevice 14. The screw plug 22 can be made from PEEK, an allograft, Ti,PE, PMMA, milled bone, steel, any other material disclosed herein, orcombinations thereof.

FIG. 8b illustrates that an interference screw 30 can anchor and fix theproximal length of the device 14 to the wall of the bone channel 22. Theinterference screw 30 can be inserted, as shown by arrow, between theproximal length of the support device 14 and the bone channel 22 and/orbetween the distal length of the support device 14 and the adjacent bone(e.g., a vertebra). The interference screw 30 can pressure-fit thesupport device 14 against the bone channel 22 and/or adjacent bone(e.g., a vertebra). The interference screw 30 can be inserted parallelwith the longitudinal axis of the length of the support device 14adjacent to the interference screw 30. The interference screw 30 canhave helical threads. The interference screw 30 can have a diameter lessthan the diameter of the bone channel 22.

FIGS. 9a through 9c illustrate that the support device 14 can haveadditional transosseous single, double, or crossing lag anchor screws32, bolts, spears, tacks, other anchors, or combinations thereof,inserted through or around the support device 14 and into surroundingbone and/or soft tissue. The anchor screws 32 can pass through thesupport device 14 or outside the support device 14 in front, back and/orto the side of the support device 14 (i.e., anterior, posterior and/orlaterally).

The outer diameter of the anchor screws 32 can be larger, smaller or thesame as the inner diameter of the bone channel 22 or tube lumen innerdiameter through which the respective screw is to be delivered. Theproximal ends of the anchor screws 32 can be threaded or smooth (e.g.,as an anchor pin). The proximal end of the anchor screws 32 can be canbe inside a larger diameter plug smaller than, equal to or larger thanthe bone channel 22 or tube lumen inner diameter. The anchor screws 32can be rigid.

FIG. 9a illustrates that a single anchor screw 32 can be insertedthrough a bone channel 22. The bone anchor screw 32 can extend throughthe device 14 and into an adjacent vertebral body. FIG. 9b illustratesthat a first anchor screw 32 a and a second anchor screw 32 b can beinserted through the bone channel 22. The first anchor screw 32 a can beinserted parallel and/or not crossing with second anchor screw 32 b.FIG. 9c illustrates that a first anchor screw 32 a can be insertedthrough a first bone channel 22 a and a second anchor screw 32 b can beinserted through a second bone channel 22 b. The first bone channel 22 acan be on the same or opposite side of the target site from the secondbone channel 22 b. The first anchor screw 32 a can overlap with thesecond anchor screw 32 b when viewed in the lateral plane.

FIG. 10 illustrates that a blocking plug 34 can be inserted into thebone channel and/or tube lumen. The blocking plug 34 can have an outerdiameter smaller than, equal to or larger than the inner diameter of thebone channel 22 and/or tube lumen. The blocking plug 34 can taper to asmaller diameter on the distal end of the blocking plug 34. The anchorscrew 32 can be fixed to and extend from the blocking plug 34. Theblocking plug 34 can be surrounded by bone cement and/or an adhesive.The blocking plug 34 can be used to center the screw. The blocking plug34 can interference fit with and fill the bone channel 22, for examplepreventing and/or minimizing migration of the support device 14 and/oranchor screw 32. The blocking plug 34 and/or anchor screw 32 canpenetrate or not penetrate the support device 14. The support device 14can make contact with (e.g., interference fit or abut) the supportdevice 14, for example to hold or brace the support device 14 in adeployed position in the target site. The blocking plug 34 can beinserted to a depth to push on the proximal end of the support device 14(e.g., to position the support device 14). The blocking plug 34 can bepositioned behind the support device 14 (e.g., at the posterior spine),pushing the support device 14 forward (e.g., distally or anteriorly) andblocking the access pathway (e.g., bone channel 22).

FIGS. 11a and 11b illustrate that a first support device 14 a and asecond support device 14 b can be inserted into the target site. Thefirst support device 14 a can be anterior or posterior, lateral ormedial, superior or inferior (e.g., in contact or in different discspaces such as a first support device 14 a in the L4-L5 space and thesecond support device 14 b in the L5-S1 space), or a combination thereofof the second support device 14 b. For example, identical diameter ordifferent diameter support devices 14 can be inserted through identicaldiameter or different diameter bone channels 22 and/or tube lumens(e.g., larger diameter support devices 14 can be inserted through largerdiameter bone channels and smaller diameter support devices 14 can beinserted through smaller bone channels). The longitudinal axis of thefirst support device 14 a can be positioned parallel with (as shown inFIG. 11b ) or non-parallel with (as shown in FIG. 11a ) the longitudinalaxis of the second support device 14 b.

Each bone channel 22 can have a medial bone channel port 36 a andlateral bone channel port 36 b.

Any or all elements of the device and/or other devices or apparatusesdescribed herein can be made from, for example, a single or multiplestainless steel alloys, nickel titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.),nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial TradingCompany, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZMalloy, for example as disclosed in International Pub. No. WO 03/082363A2, published 9 Oct. 2003, which is herein incorporated by reference inits entirety), tungsten-rhenium alloys, for example, as disclosed inInternational Pub. No. WO 03/082363, polymers such as polyethyleneteraphathalate (PET)/polyester (e.g., DACRON® from E. I. Du Pont deNemours and Company, Wilmington, Del.), polypropylene, (PET),polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone(PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK)(also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),absorbable or resorbable polymers such as polyglycolic acid (PGA),polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA),polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extrudedcollagen, silicone, zinc, echogenic, radioactive, radiopaque materials,a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone) any of the other materials listed herein or combinations thereof.Examples of radiopaque materials are barium sulfate, zinc oxide,titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

Any or all elements of the device and/or other devices or apparatusesdescribed herein, can be, have, and/or be completely or partially coatedwith agents and/or a matrix a matrix for cell ingrowth or used with afabric, for example a covering (not shown) that acts as a matrix forcell ingrowth. The matrix and/or fabric can be, for example, polyester(e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington,Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone orcombinations thereof.

The device and/or elements of the device and/or other devices orapparatuses described herein and/or the fabric can be filled, coated,layered and/or otherwise made with and/or from cements, fillers, glues,and/or an agent delivery matrix known to one having ordinary skill inthe art and/or a therapeutic and/or diagnostic agent. Any of thesecements and/or fillers and/or glues can be osteogenic and osteoinductivegrowth factors.

Examples of such cements and/or fillers includes bone chips,demineralized bone matrix (DBM), calcium sulfate, corallinehydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,polymethyl methacrylate (PMMA), biodegradable ceramics, bioactiveglasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs)such as recombinant human bone morphogenetic proteins (rhBMPs), othermaterials described herein, or combinations thereof.

The agents within these matrices can include any agent disclosed hereinor combinations thereof, including radioactive materials; radiopaquematerials; cytogenic agents; cytotoxic agents; cytostatic agents;thrombogenic agents, for example polyurethane, cellulose acetate polymermixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious,hydrophilic materials; phosphor cholene; anti-inflammatory agents, forexample non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 inHypoxic Vascular Endothelium, J. Biological Chemistry 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties.

U.S. Pat. No. 13/592,271 and PCT Application No. US12/51945, both filedAug. 22, 2012, are incorporated by reference herein in their entireties.The broach can be used to perform the discectomy. The elements andcharacteristics of the broach can be the same as those for the supportdevice 14.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The above-described configurations,elements or complete assemblies and methods and their elements forcarrying out the invention, and variations of aspects of the inventioncan be combined and modified with each other in any combination.

We claim:
 1. A biological implant support device for providingorthopedic support comprising: a first rigid section at a first terminallongitudinal end of the device; a second rigid section rotatablyattached to the first rigid section at a longitudinal end of the firstrigid section away from the first terminal longitudinal end of thedevice; and wherein second rigid section comprises a thread.
 2. Thedevice of claim 1, further comprising an axle rotatably attaching thefirst rigid section to the second rigid section.
 3. A system forproviding orthopedic support comprising: the device of claim 1; and afirst screw attached to and extending away from device.
 4. The system ofclaim 3, further comprising a second screw attached to and extendingaway from device.
 5. A system for providing orthopedic supportcomprising: the device of claim 1; and a plug abutting the device. 6.The system of claim 5, wherein the plug comprises a thread.